BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2143415 · Received June 29, 2011

    Report

    Report Number
    2050012-2011-02517
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011. THE FSE PERFORMED TROUBLESHOOTING, SERVICED THE INSTRUMENT AND NO DRIPPING SEEN BY FSE. ON (B)(6) 2011, CUSTOMER REPORTED TO FSE THAT LEAKING CONTINUED. THE FSE REPLACED THE A/B ASSEMBLY; HOWEVER, LEAKING WAS STILL OBSERVED BY FSE. THE FSE EXAMINED INSTRUMENT FURTHER AND FOUND THE VACUUM VALVE WAS NOT OPENING FOR THE REAGENT PROBE. THE FSE TOOK VALVE APART AND CLEANED. NO FURTHER LEAKING OBSERVED BY FSE. REPAIR VERIFIED PER ESTABLISHED PROCEDURES. AN MDR NUMBER: 2050012-2011-02516 WAS SUBMITTED IN ASSOCIATION WITH A LEAK ON THIS INSTRUMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED THAT THEY CONTINUED TO GET CUVETTES FAILING WATER BLANK TEST AND OBSERVED LEAKING FROM REAGENT PROBES. THE ISSUES WERE ASSOCIATED WITH THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. A CUSTOMER TECHNICAL SUPPORT (CTS) GENERATED A SERVICE REQUEST. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1